BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOBALLOON ABLATION SYSTEM

    MDR report key: 6668022 · Received June 26, 2017

    Report

    Report Number
    3008780134-2017-00008
    Event Type
    Injury
    Date Received
    June 26, 2017
    Date of Event
    May 30, 2017
    Report Date
    June 7, 2017
    Manufacturer
    C2 THERAPEUTICS, INC
    Product Code
    GEH
    PMA / PMN Number
    K161202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEVELOPED NARROWING OF THE ESOPHAGUS (STRICTURE) AFTER CRYOABLATION; STRICTURE REQUIRED TREATMENT WITH BALLOON DILATION. TREATMENT WAS SUCCESSFUL; THERE WERE NO SEQUELAE. STRICTURE IS AN EXPECTED ADVERSE EVENT AFTER ABLATION. STRICTURE IS PROCEDURE - RELATED. NO DEVICE RETURNED; FEEDBACK ANALYZED.

    Description of Event or Problem · 1

    STUDY PATIENT; INITIAL PROCEDURE PERFORMED WITH THE C2 CRYOBALLOON ABLATION DEVICE ON (B)(6) 2017. NO ISSUE REPORTED. DURING THE 3-MONTH FOLLOW UP VISIT, IN (B)(6) 2017, A NARROWING OF THE ESOPHAGUS WAS NOTED DURING THE ENDOSCOPY. CRYO ABLATION PROCEDURE WAS ATTEMPTED, BUT BECAUSE OF A SUB-CLINICAL NARROWING IN THE ESOPHAGUS, CRYOBALLOON WOULD NOT STAY INFLATED AND CRYO ABLATION COULDN'T BE PERFORMED. THE PATIENT WAS TREATED WITH APC. THE CASE WAS NOT REPORTED TO C2. DURING THE 6-MONTH FOLLOW UP VISIT, (B)(6) 2017 A MODERATE STRICTURE WAS OBSERVED AND DILATION WAS PERFORMED THE SAME DAY. THIS ADVERSE EVENT SEVERITY IS REPORTED AS MILD AND ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449385 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT WITH ACCESSORIES GEH C2 THERAPEUTICS, INC FG 1012 UKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention