CRYOBALLOON ABLATION SYSTEM

K101825 · C2 Therapeutics · GEH · Sep 29, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101825
• Device Name: CRYOBALLOON ABLATION SYSTEM
• Applicant: C2 Therapeutics
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Sep 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The C2 Therapeutics CryoBalloon Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

Device Story

CryoBalloon Ablation System is a cryosurgical tool for endoscopic tissue destruction. System components: catheter with balloon probe, handle with trigger-controlled refrigerant delivery valve, and liquid nitrous oxide cartridge. Physician-operated during endoscopic procedures (3.7mm accessory channel). Operation: balloon probe inflated and cooled with nitrous oxide; balloon contacts esophageal wall to ablate tissue via extreme cold. Nitrous oxide remains contained within balloon; gas exits through catheter proximal end. Device is single-patient, one-time continuous application use. Internal 9VDC battery powers cartridge heater. Output is thermal energy for tissue ablation; physician monitors procedure via endoscope to guide placement and assess tissue destruction. Benefits include targeted tissue ablation for general surgical applications.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by biocompatibility, performance, and animal test results.

Technological Characteristics

Cryosurgical unit; nitrous oxide-cooled balloon probe. Components: catheter (sterile), handle (non-sterile, 9VDC lithium battery), nitrous oxide cartridge (non-sterile). Thermal ablation principle. Endoscopic form factor. Standalone operation.

Indications for Use

Indicated for the destruction of unwanted tissue in general surgery, specifically for endoscopic applications.

Regulatory Classification

Identification

(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.

Predicate Devices

• CryMed Technologies SprayGenix™ Ablation System (K060555)
• CSA Medical CryoSpray Ablation System (K070893)
• GI Supply Polar Wand Cryotherapy System (K021387)
• Barrx Medical HALO360 Coagulation System (K051168)

Submission Summary (Full Text)

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101825

CONFIDENTIAL

# Section 5-510(k) Summary or 510(k) Statement

t

#### I. General Information

Submitter: C2 Therapeutics, Inc. SEP 2 9 2010 303 Convention Way, Suite 1 Redwood City, CA 94063 Contact Person: Anne Worden Regulatory Consultant 925-895-1200 Summary Preparation Date: 6/30/2010

#### II. Names

Device Names: CryoBalloon Ablation System

Primary Classification Names: Cryosurgical unit with a nitrous oxide cooled balloon probe and accessories

#### III. Predicate Devices

- CryMed Technologies SprayGenix™ Ablation System K060555 .
- CSA Medical CryoSpray Ablation System K070893 .
- GI Supply Polar Wand Cryotherapy System K021387 .
- Barrx Medical HALO360 Coagulation System - K051168 .

## IV. Product Description

The CryoBalloon Ablation System ("System") is used to destroy unwanted tissue by application of extreme cold. Upon activation by a physician, the balloon probe at the end of the catheter is simultaneously inflated and cooled with nitrous oxide. The balloon probe comes in contact with the wall of the esophagus and ablates unwanted tissue. Nitrous oxide is fully contained within the balloon probe and does not contact the esophagus. The nitrous oxide gas exits the patient through the proximal end of the catheter. The CryoBalloon Ablation System is designed for one time, continuous application use (single patient) in conjunction with a therapeutic endoscope (3.7mm accessory channel ID). The System is comprised of the following main components:

- CryoBalloon Ablation Catheter (REF FG-1000) consists of a connector, catheter . shaft, balloon probe, and protective sheath. This is supplied sterile.
- CryoBalloon Ablation Handle (REF FG-1001) contains the cartridge heater and . refrigerant delivery valve which is controlled via the trigger. The unit is internally powered (9VDC non-replaceable lithium battery pack) and supplied non-sterile.
- CryoBalloon Ablation Cartridge (REF FG-1002) contains liquid nitrous oxide. The . Cartridge is supplied non-sterile and contains enough refrigerant for one to two ablation sites.

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### V. Indications for Use

The C2 Therapeutics CryoBalloon Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

#### VI. Rationale for Substantial Equivalence

The CryoBalloon Ablation System shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent for use to the predicate devices as a cryosurgical unit with a nitrous oxide cooled balloon probe and accessories.

In addition, comparative performance test data demonstrated adequate device performance and safety.

| Comparison<br>Characteristic | K10 | K070893 & K060555 | K021387 | K051168 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Brand Name | CryoBalloon<br>Ablation System | CryoSpray Ablation™<br>& SprayGenix™ Cryo | Polar Wand<br>Cryotherapy System | HALO 360<br>Coagulation System |
| Intended Use | | | | |
| Intended Use | Destruction of<br>unwanted tissue with<br>extreme cold | Destruction of<br>unwanted tissue with<br>extreme cold | Ablation of unwanted<br>tissue with extreme cold | RF for tissue<br>coagulation |
| Indications for<br>Use | Intended to be used as<br>a cryosurgical tool for<br>destruction of<br>unwanted tissue in<br>the field of general<br>surgery, specifically<br>for endoscopic<br>applications. | Intended to be used as a<br>cryosurgical tool for<br>destruction of unwanted<br>tissue in the field of<br>general surgery,<br>specifically for<br>endoscopic applications. | Used for ablation of<br>unwanted tissue in the<br>fields of dermatology,<br>gynecology, general<br>surgery, urology, and<br>gastroenterology. The<br>system may be used<br>with a variety of<br>cryogens, e.g. carbon<br>dioxide, nitrous oxide,<br>argon, krypton | Indicated for use in the<br>coagulation of bleeding<br>and non-bleeding sites<br>in the gastrointestinal<br>tract including but not<br>limited to the<br>esophagus. Indications<br>include Esophageal<br>Ulcers, Mallory-Weiss<br>tears, Arteriovenous<br>Malformations,<br>Angiomata, Barrett's<br>esophagus, Dieulafoy<br>Lesions, and<br>Angiodysplasia. |
| Key Technical Characteristics | | | | |
| Control | User | User | User | User |
| Method of<br>Action | Thermal | Thermal | Thermal | Thermal |
| Endoscopic<br>procedure | Yes | Yes | Yes | Yes |

See Table 9 - Substantial Equivalence Comparison of Intended Use and Technical Characteristics for comprehensive analysis of Technical Characteristics.

#### Safety and Effectiveness Information VII.

The review of the indications for use and technical characteristics provided demonstrates that the CryoBalloon Ablation System is substantially equivalent to the predicate devices.

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Biocompatibility, performance and animal test results demonstrated the safety and effectiveness of the CryoBalloon Ablation System.

## VIII. Conclusion

The CryoBalloon Ablation System was found to be substantially equivalent to the predicate devices.

The CryoBalloon Ablation System shares identical indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 2 9 2010

C2 Therapeutics, Inc. % Mr. Peter Garcia-Meza President and CEO 303 Convention Way, Suite 1 Redwood City, California 94063

Re: K101825

Trade/Device Name: CyroBalloon Ablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: June 30, 2010 Received: July 01, 2010

Dear Mr. Garcia-Meza:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

:

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Page 2 - Mr. Peter Garcia-Meza

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersQffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL

Indications for Use Statement

510(k) Number (if known): K10 | 82 ・

Device Name: CryoBalloon Ablation System

Indications for Use:

The C2 Therapeutics CryoBalloon Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

| Prescription Use | ✓ |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------------------------|---------|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K10/825 |

Page 1 of 1C2 Therapeutics Premarket Notification 510(k) Submission for: CryoBalloon Ablation System

Section 4: Indications for Use - Page 4-2