MAUDE Adverse Event Report: C2 THERAPEUTICS, INC. C2 CRYOBALLOON ABLATION SYSTEM; CRYOSURGICAL UNIT, CRYOGENIC

Model Number FG1012, FG1009

Device Problem No Apparent Adverse Event (3189)

Patient Problem Laceration(s) (1946)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

The customer reported placing a clip after observing a mucosal tear.The returned catheter was visually inspected for issues that may have contributed to the user's observation.No nonconformances or defects were identified on the devices.The data from the returned controller was downloaded and analyzed.The data shows five ablation cycles; which are comprised of four complete 10-second treatments and one partial 10-second treatment due to the operator releasing the trigger.The partial cycle occurred on the fourth treatment.The peak balloon pressure was 3.95 psig and occurred on the first treatment.The returned catheter was tested with the returned controller and no issues were identified, and the device was found to operate within specifications.The root cause of the customer's observation was unable to be determined from the device analysis and did not appear to be related to any device malfunction.

Event Description

Patient experienced a mucosal tear.The tear was clipped as a precautionary step because the patient was on plavix and aspirin.The bleeding appeared to stop prior to placing the clip, but the physician proceeded with clipping out of caution.This was the second cryoballoon treatment for this patient.

• Brand Name: C2 CRYOBALLOON ABLATION SYSTEM
• Type of Device: CRYOSURGICAL UNIT, CRYOGENIC
• Manufacturer (Section D): C2 THERAPEUTICS, INC.; 303 convention way; suite 1; redwood city CA 94063
• Manufacturer (Section G): C2 THERAPEUTICS, INC.; 303 convention way; suite 1; redwood city CA 94063
• Manufacturer Contact: theresa brandner-allen ; 303 convention way; suite 1; redwood city, CA 94063 ; 6505215921
• MDR Report Key: 5890855
• MDR Text Key: 52608328
• Report Number: 3008780134-2016-00009
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/14/2016
• Device Model Number: FG1012, FG1009
• Device Catalogue Number: FG1012, FG1009
• Device Lot Number: 06102016-01, 04222016-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 88