MAUDE Adverse Event Report: C2 THERAPEUTICS CRYOBALLOON FOCAL ABLATION SYSTEM; CRYOSURGICAL UNIT WITH ACCESSORIES

Model Number FG 1012 / FG 1012

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

Controller ln 03142018-02 sn (b)(4): the data was downloaded and reviewed.Data shows one full ablation and multiple high balloon pressure errors thus confirming the user's narrative; balloon will automatically deflate when a high pressure is sensed as a safety mechanism.The controller was run with a known working catheter.Four 8 second ablations were performed and no issues were observed, controller performed as intended.This suggest that the issue may have been within the catheter.However, the catheter was not returned, thus a definitive root cause could not be determined.Often a kink in the catheter shaft may result in high balloon pressure, but without the catheter in hand to inspect this cannot be confirmed.Controller ln 03142018-02 sn (b)(4): the data was downloaded and reviewed.Data shows one ablations and no errors that would suggest that the balloon deflated.The controller was run with a known working catheter.Four 8-second ablations were performed and no issues were observed; the controller functioned as intended.This suggest that the issue lies within the catheter.However, the catheter was not returned to be investigated thus the root cause is inconclusive.

Event Description

C2 therapeutics became aware of device malfunction on 08may2018: on 08 may 2018 c2 personnel received two controllers from rma with a marking on the original cryoballoon focal controller box.The markings read "multiple alarms/alerts.(b)(6) 2018.Same patient:" on 11 may 2018 additional information was received from customer via sales representative.It was reported that the balloon would deflate constantly even after changing the controller.Customer was able to do four ten second ablations and then aborted due to the constant balloon deflation issue.The customer used a cryoballoon focal pear catheter.It was also reported that there were contractions and pre-existing scar tissue and it was challenging to treat the patient.

• Brand Name: CRYOBALLOON FOCAL ABLATION SYSTEM
• Type of Device: CRYOSURGICAL UNIT WITH ACCESSORIES
• Manufacturer (Section D): C2 THERAPEUTICS; 303 convention way, suite 1; redwood city CA 94063
• Manufacturer (Section G): C2 THERAPEUTICS; 303 convention way, suite 1; redwood city CA 94063
• Manufacturer Contact: andy wong ; 303 convention way, suite 1; redwood city, CA 94063 ; 4088363524
• MDR Report Key: 7571187
• MDR Text Key: 110584060
• Report Number: 3008780134-2018-00021
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 85492400612
• UDI-Public: 85492400612
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/16/2018
• Device Model Number: FG 1012 / FG 1012
• Device Catalogue Number: FG 1012 / FG 1012
• Device Lot Number: 03142018-02 / 03142018-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2018
• 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