BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOBALLOON FOCAL ABLATION SYSTEM

    MDR report key: 5817734 · Received July 22, 2016

    Report

    Report Number
    3008780134-2016-00008
    Event Type
    Injury
    Date Received
    July 22, 2016
    Date of Event
    June 29, 2016
    Report Date
    July 22, 2016
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K131523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE ON (B)(6) 2016 WAS PERFORMED WITHOUT INCIDENT; THERE WERE NO ISSUES WITH DEVICES, USER, OR PATIENT. THIS EVENT IS BEING REPORTED OUT AN ABUNDANCE OF CAUTION FOR POSSIBLE EFFECTS FROM THE PREVIOUS ABLATION PERFORMED WITH A C2 CRYOBALLOON DEVICE ON (B)(6) 2016, ALTHOUGH THIS INITIAL CASE WAS ALSO PERFORMED WITHOUT ANY ISSUES.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A MALE PATIENT, AGE (B)(6), WAS TREATED FOR HIATAL HERNIA=3CM. CASE WENT WELL; THERE WAS NO ISSUE WITH A PATIENT OR DEVICE. DURING THE CASE ON (B)(6) 2016, THE C2 COMPANY REPRESENTATIVE BECAME AWARE OF THE ADDITIONAL INFORMATION CONCERNING A HISTORY OF THIS PATIENT: ON (B)(6) 2016, THE PATIENT HAD HIS FIRST BARRETT'S TREATMENT WITH THE C2 CRYOBALLOON ABLATION SYSTEM, BALLOON CRYOTHERAPY, WHERE 6 CM WAS TREATED WITH 16 ABLATIONS. THERE WAS NO COMPLICATION WITH THIS PROCEDURE. ON (B)(6) 2016, THE PATIENT CALLED THE DOCTOR DUE TO DYSPHAGIA, ADMITTING THAT HE HADN'T TAKEN THE CARAFATE AS PRESCRIBED. THERE WAS A STRICTURE PRESENT. DOCTOR DID TTS BALLOON DILATION (18-19-20 MM SIZES). THE C2 CRYOBALLOON ABLATION SYSTEM WAS NOT USED IN THIS PROCEDURE. C2 WAS UNAWARE OF THIS PROCEDURE UNTIL (B)(6) 2016. ON (B)(6) 2016, THE C2 CRYOBALLOON ABLATION SYSTEM TREATMENT FOR HIATAL HERNIA=3CM. CASE WENT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468996 CRYOBALLOON FOCAL ABLATION SYSTEM CRYOSURGICAL UNIT, CRYOGENIC GEH C2 THERAPEUTICS, INC. FG 1012 04112016-04

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention