BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 4623241 · Received March 19, 2015

    Report

    Report Number
    3004534508-2015-00001
    Event Type
    Injury
    Date Received
    March 19, 2015
    Date of Event
    March 4, 2009
    Report Date
    March 17, 2015
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    PMA / PMN Number
    K072651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT UPPER GI ENDOSCOPY WITH SPRAY CRYOTHERAPY FOR BARRETT'S ESOPHAGUS WITH DYSPLASIA ON (B)(6) 2009. THE PATIENT HAD A LARGE HIATAL HERNIA (APPROXIMATELY 7 CM). THE PROCEDURE WAS WELL TOLERATED AND WITHOUT ANY COMPLICATIONS NOTED. I TREATED TWO SITES X2 WITH 20 SECOND FREEZES. THE DECOMPRESSION TUBE APPEARED TO WORK NICELY DURING THE PROCEDURE AND THE PATIENT RECOVERED WITHOUT DIFFICULTY. HE DEVELOPED MELENA ON (B)(6) 2009. EGD WAS PERFORMED ON (B)(6) AND HE HAD EVIDENCE OF AN ULCERATION WITH A BLEEDING VESSEL IN THE DISTALESOPHAGUS WHERE HE HAD UNDERGONE CRYOTHERAPY. HE WAS TREATED BY PLACEMENT OF AN ENDOCLIP. HE DID REQUIRE HOSPITALIZATION. I DO NOT HAVE THE HOSPITAL RECORDS AT THIS TIME AND THEY CAN BE REQUESTED IF NEEDED. THE PATIENT DID ADMIT THAT HE HAD UTILIZED ALEVE INTERMITTENTLY AFTER THE PROCEDURE DESPITE MY INSTRUCTIONS AND ALSO HAD CONSUMED SOME ALCOHOL. SUBSEQUENT EXAMINATIONS HAVE BEEN WITHOUT ANY COMPLICATIONS AND HE HAS RESPONDED NICELY TO ABLATION WITH NO RESIDUAL BARRETT'S ESOPHAGUS OR DYSPLASIA. HIS SUBSEQUENT MEDICAL COURSE IS SIGNIFICANT FOR A DIAGNOSIS OF MULTIPLE MYELOMA, WHICH HAS ALSO BEEN TREATED SUCCESSFULLY, AND HE APPEARS TO BE IN GOOD HEALTH AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187477 CRYOSPRAY ABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL CC2-NAM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R